Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031977134

FEI Number

3031977134

Entity Name

bioMerieux, Inc.

City/State/Country

Morrisville, NC, US

Establishment Address

3015 Carrington Mill Blvd, Morrisville, NC 27560, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BIOMERIEUX SA (Owner Number: 8020790)

Owner / Operator Contact Address

Chemin De L Orme, Marcy L Etoile, FR-69 69280, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181766

PMA Number

N/A

All Registered Proprietary Names

VITEK 2 AST- Gram Positive Telavancin VITEK 2 AST - Gram Negative Imipenem VITEK 2 AST Streptococcus Ceftriaxone VITEK 2 AST-Yeast Caspofungin VITEK 2 GP Telithromycin for S. pneumo AST Streptococcus Vancomycin VITEK 2 Streptococcus Tetracycline VITEK 2 Gram Positive Erythromycin VITEK 2 Gram Positive Ertapenem VITEK 2 GRAM POSITIVE DOXCYCLINE VITEK 2 Gram Positive Tigecycline VITEK 2 AST-Gram Positive Moxifloxacin VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE VITEK 2 AST-Yeast Voriconazole VITEK 2 Gram Positive Daptomycin VITEK 2 Gram Positive Gatifloxacin BACT/ALERT PF PLUS CULTURE BOTTLE VITEK 2 AST-GN Levofloxacin VITEK 2 AST-GP Penicillin G VITEK 2 AST-GP Streptomycin, HL VITEK 2 AST-GP Clindamycin VITEK 2 AST-GN Imipenem VITEK 2 AST-GN Tobramycin VITEK 2 AST-GP Ciprofloxacin VITEK 2 AST-GN Cefazolin VITEK 2 AST-GP Erythromycin VITEK 2 AST-GP Gentamicin, HL VITEK 2 AST-GN Cefpodoxime VITEK 2 AST-GP for S.pn Penicillin G VITEK 2 AST-GN Tetracycline VITEK 2 AST-GP for S.pn Ofloxacin VITEK 2 AST-GN Cefalotin VITEK 2 AST-GP Levofloxacin VITEK 2 AST-GN Cefuroxime VITEK 2 AST-GP Rifampin VITEK 2 AST-GN Meropenem VITEK 2 AST-GN Ceftriaxone VITEK 2 AST-GP Sparfloxacin VITEK 2 AST-GN Gentamicin VITEK 2 AST-GN Ampicillin VITEK 2 AST-GP Gentamicin VITEK 2 AST-GP for S.pn Tetracycline VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn) VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid VITEK 2 AST-GP for S.pn Chloramphenicol VITEK 2 AST-GP Amp/Sulbactam VITEK 2 AST-GN Nitrofurantoin VITEK 2 AST-GN Amox/Clav VITEK 2 AST-GN Nalidixic Acid VITEK 2 AST-GN Ciprofloxacin VITEK 2 AST-GP for S.pn Cefotaxime VITEK 2 AST-GN Amp/Sulbactam VITEK 2 AST-GN Piperacillin VITEK 2 AST-GP Cefazolin VITEK 2 AST-GN Ticarcillin VITEK 2 AST-GN Cefoxitin VITEK 2 AST-GP for S.pn Trimeth./sulfa VITEK 2 AST-GN Pip/Tazob. VITEK 2 AST-GP Chloramphenicol VITEK 2 AST-GN Amikacin VITEK 2 AST-GN Norfloxacin VITEK 2 AST-GP Norfloxacin VITEK 2 AST-GN Cefepime VITEK 2 AST-GN Trimeth./sulfa VITEK 2 AST-GP Nitrofurantoin VITEK 2 AST-GP Ofloxacin VITEK 2 AST-GN Ceftazidime VITEK 2 AST-GP for S.pn Vancomycin VITEK 2 AST-GP Minocycline VITEK 2 AST-GN Cefotaxime VITEK 2 AST-GN Aztreonam VITEK 2 AST-GN Cefotetan VITEK 2 AST-GP for S.pn Ceftriaxone VITEK 2 AST-GN Ceftizoxime VITEK 2 AST-GP Vancomycin VITEK 2 AST-GP Tetracycline VITEK 2 AST-GP Ampicillin VITEK 2 AST-GP Oxacillin VITEK 2 Gram Positive Linezolid AST-GN Imipenem VITEK 2 AST-GN Amikacin BacT/ALERT 3D with Mycobacterium Indication VITEK 2 AST-GN Ciprofloxacin VITEK 2 AST-Gram Positive Cefoxitin Screen VITEK 2 GP Amoxicillin for S pneumo VITEK 2 AST-Gram Negative Omadacycline DensiCHEK Plus VITEK 2 Compact VITEK 2 Gram Negative Tigecycline VITEK 2 AST-Gram Positive Fosfomycin BACT/ALERT FN PLUS VITEK 2 GN Doxycycline VITEK 2 AST-GN Piperacillin/tazobactam VITEK 2 AST-Streptococcus Penicillin VITEK 2 AST- Gram Negative Polymyxin B VITEK 2 AST-ST Erythromycin VITEK 2 Streptococcus Tetracycline VITEK 2 Gram Negative Ceftriaxone VITEK 2 GP Sparfloxacin for S.pn VITEK DENSICHEK VITEK 2 ESBL Test VITEK 2 AST-ST Ampicillin VITEK 2 AST-GP Ceftaroline VITEK 2 Gram Positive Vancomycin VITEK 2 AST-Gram Negative Tobramycin BacT/ALERT FA (Plastic Bottle) AST Clindamycin VITEK 2 AST-Gram Negative Levofloxacin and BacT/ALERT 3D60 Instrument 3D Combination BacT/ALERT Blood Culturing System (240), S. pneumo VITEK 2 GP Levofloxacin for VITEK 2 AST-Gram Negative Piperacillin / Tazobactam VITEK 2 Gram Negative Levofloxacin VITEK 2 AST-GN Tigecycline VITEK 2 AST-ST Levofloxacin VITEK 2 AST-Gram Negative Plazomicin VITEK 2 Streptococcus Penicillin VITEK 2 Gram Negative Piperacillin Trimethoprim / Sulfamethoxazole VITEK 2 Gram Positive VITEK 2 AST-Gram Negative Meropenem/Vaborbactam VITEK® 2 AST-GN Gentamicin VITEK 2 Streptococcus Trimethoprim/Sulfamethoxazole S. pneumo VITEK 2 GP Erythromycin for BacT/ALERT SN (Plastic Bottles) VITEK 2 AST-ST Inducible Clindamycin Resistance VITEK 2 Gram Positive VRSA Screen VITEK 2 AST - Gram Negative Ertapenem VITEK 2 Gram Negative Doripenem VITEK 2 AST-ST Clindamycin VITEK 2 Gram Negative Gatifloxacin VITEK 2 Gram Positive Meropenem VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) VITEK 2 AST-ST Tigecycline VITEK 2 AST-Gram Positive Lefamulin VITEK 2 AST-Gram Negative Minocycline DensiCHEK Plus AST Penicillin VITEK 2 AST-Gram Positive Linezolid VITEK 2 AST-Gram Positive Daptomycin Vitek 2 AST Gram Negative Cefazolin VITEK 2 AST-Gram Positive Dalbavancin VITEK 2 AST-ST Meropenem VITEK 2 AST-Gram Negative Ciprofloxacin VITEK 2 Gram Positive Inducible Clindamycin Resistance VITEK2 AST-Gram Negative Delafloxacin VITEK 2 AST Gram Negative Cefotaxime VITEK 2 AST-Gram Negative Ceftazidime BACT/ALERT MP Reagent System BacT/ALERT FN (Plastic Bottles) AST Cefotaxime BacT/ALERT VIRTUO Microbial Detection System VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-08-10
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2022-08-10
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-08-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-21
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-21
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-21
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-09-17
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2022-07-13
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-07-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-07-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2010-02-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-01-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-02-08
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-02-08
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-02-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-01-03
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-18
NGZ	Susceptibility Test Plate, Antifungal	Microbiology	Class 2	866.1640	2024-06-18
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	Class 2	866.1640	2024-06-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-06-18
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2024-06-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2013-03-05
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-25
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-12-22
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-12-22
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-12-22
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-19
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-06-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-10-18
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2022-10-18
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2022-10-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-06-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2010-02-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-09-16
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2015-08-10
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-10-24
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-10-24
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-10-24
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2020-02-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2020-02-17
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2020-02-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-02-07
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-01-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-11-05
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-06-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-20
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-20
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-02-20
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-06-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-06-27
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2021-09-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-01-25
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-01-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-01-25
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-14
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-03-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-03-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2023-03-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-11-03
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-01-02
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-27
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-01
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-01
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2012-03-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-11-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2016-05-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2016-05-09
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2016-05-09
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2010-02-18
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2011-10-14
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-11
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-01-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-12-04
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2024-03-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2024-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-03-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-03-08
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-08
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-08
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2009-12-23
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-02-07
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-07-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2023-02-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-06-17
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-12-04
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2022-06-21
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2015-11-18
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-13
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-03-13
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-03-13
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-16
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2017-02-16
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2017-02-16
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2020-10-15
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2020-10-15
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2020-10-15
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2019-05-16
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2007-12-27
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2013-01-30
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-04-04
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2019-02-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2019-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOMERIEUX SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1450405	BIOMERIEUX, INC.	LOMBARD, IL, US
3023036790	Specific Diagnostics	San Jose, CA, US
3025775667	BIOMERIEUX, INC.	Salt Lake City, UT, US
3008249922	BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26
K232967	bioMerieux, Inc.	VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)	2024-06-12
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K010508	Pasco Laboratories, Inc.	PASCO MIC AND MIC/ID PANELS	2001-04-23
K111394	Siemens Healthcare Diagnostics, Inc.	MICROSCAN MICROSTEP	2011-06-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0028-2014	Becton Dickinson & Co. BD Diagnostic Systems	1	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

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3007502289	Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, MX
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031977134. Last updated year: 2026. Please use registration number 3031977134 when referencing this establishment in official correspondence.